promethazine/phenylephrine/codeine - oral
GENERIC NAME: PROMETHAZINE/PHENYLEPHRINE/CODEINE - ORAL (pro-METH-uh-zeen/fen-ill-EFF-rin AND KO-deen)
WARNING: Children should not use products that contain codeine after certain surgeries (including tonsil/adenoid removal). Also, this medication should not be used in children younger than 6 years due to an increased risk for serious (rarely fatal) breathing problems such as slow/shallow breathing. This infrequent side effect may occur even with usual prescribed doses. The lowest effective dose should be used, and other drugs that may slow down breathing should be avoided. For children between 6 and 12 years old, do not use this product to treat cough or pain unless specifically directed by the doctor. Some manufacturers also recommend that promethazine and other drugs that may also slow down breathing (such as the codeine in this product) should not be used together in children younger than 16 years. Get medical help right away if you notice symptoms of slow/shallow breathing (See also Side Effect section). Talk with your doctor or pharmacist about the risks and benefits of this medication.
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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